AcrySof™ IQ Vivity™ DFT015 (REF DFT015.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652421218), received between Mar 5, 2021 and Sep 21, 2024 — classified as 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2024Failure to Eject; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DID NOT IMPLANT INTO EYE CORRECTLY. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20275018 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT HAD BLURRY VISION, UNEXPECTED REFRACTION, DRYNESS, UNABLE TO READ AND POSTERIOR CAPSULE FIBROSIS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT IOL WAS STILL INSIDE PATIENT'S EYE AND SO FAR NO ANY MEDICAL INTERVENTION REQUIRED.

  Patient problems: Blurred Vision; Dry Eye(s); Posterior Capsule Opacification; Visual Impairment

  MAUDE report 20199788 ↗
• InjuryNov 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRA-OCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THAT LENS HAD GLISTENINGS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN RECEIVED INCLUDES PATIENT HAD FEMTO LASER SURGERY ON BOTH EYES AFTER CATARACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161005 ↗
• InjurySep 6, 2023Defective Component; Malposition of Device; Defective Component; Malposition of Device

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT DURING IMPLANTATION THE CAPSULAR BAG WAS RUPTURED.

  Patient problems: Insufficient Information

  MAUDE report 17690197 ↗
• InjuryJul 17, 2023Packaging Problem; Scratched Material; Packaging Problem; Scratched Material

  A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN OPENING THE BOX OF THE LENS, IT WAS NOT PROPERLY PLACED IN THE CONTAINER, THE OPTICAL SOCKET WAS ON THE PLASTIC PIVOTS. WHEN IMPLANTING THE LENS IN THE PATIENT'S EYE, IT IS OBSERVED THROUGH THE MICROSCOPE THAT THE LENS PRESENTS MARKS AND SCRATCHES ON THE OPTICAL TAKE, IT WAS DECIDED TO WAIT FOR THE EVOLUTION OF THE PATIENT IN POST-SURGICAL CONTROL TO DETERMINE IF IT GENERATES SYMPTOMS AND DEFINE THE BEHAVIOR. FOUR FRACTURES IN THE OPTICAL ZONE COMPROMISING THE CENTRAL RINGS NOTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING, IN THE LAST POST-SURGICAL CONTROL, THE FOUR FRACTURES ARE OBSERVED IN THE OPTIC ZONE, ONE OF THEM COMPROMISING THE CENTRAL RINGS, WITH CAPSULAR OPACITY. PATIENT WAS NOT SEEING WELL OUT OF THE RIGHT EYE. THE LENS WAS REMOVED FROM THE PATIENT'S EYE AND REPLACED WITH ANOTHER IDENTICAL LENS WITHOUT COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 17332948 ↗
• MalfunctionJun 9, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, MARK ON THE LENS IN THE CENTER OF THE OPTICAL ZONE WAS NOTED. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100102 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED POSTERIOR CAPSULAR TEAR, VITRECTOMY NEEDED TO BE PERFORMED, INTRAOCULAR LENS TRIED TO ROTATE IN DISTAL HAPTIC BUT NOT RESISTANCE.

  Patient problems: Capsular Bag Tear

  MAUDE report 16886239 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EPITHELIAL EDEMA AT THE 1,5/2-HOUR INCISION, OCP+1 (OCULAR CICATRICIAL PEMPHIGOID). THE DIAGNOSIS WAS MYOPIZATION, ASTIGMATISM INCREASE. THE SURGEON PRESCRIBED STEROIDS, ANTI-INFLAMMATORY DRUGS AND TREHALOSE. THE PATIENT HAD DECREASE IN VISUAL ACUITY (6/10) AFTER SEVERAL MONTHS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND UPDATED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Corneal Edema; Inflammation; Visual Impairment

  MAUDE report 16580581 ↗
• InjuryJan 17, 2023Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A CENTRAL DEFECT. THE LENS WAS EXPLANTED AND REPLACED BY THE STANDBY LENS IN A SECONDARY PROCEDURE AFTER TWO DAYS OF INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16183681 ↗
• InjuryNov 14, 2022Malposition of Device; Malposition of Device

  A PHYSICIAN REPORTED THE FOLLOWING AFTER THE PHACOEMULSIFICATION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE NEXT DAY OF IMPLANT, THE VISUAL ACUITY (VA) WAS WITH A DIAPHRAGM OF 0.6 AND THE PUPIL WAS 5.0 MM (POSTOPERATIVE MYDRIASIS), THE IOL POSITION WAS CORRECT. THREE WEEKS AFTER, THE PATIENT COMPLAINTS OF DECREASED VISION, ESPECIALLY NEAR. VA IS OF 0.4 WITHOUT CORRECTION, WITH CORRECTION WITH DIAPHRAGM 0.6 N/A, PUPIL 4.0MM. DECENTERED IOL WAS NOTED, DISPLACED DOWNWARD AND TO THE RIGHT RELATIVE TO THE CENTER OF THE PUPIL. THE CENTRALIZATION OF THE IOL WAS PERFORMED. IOL CENTERED ON THE PUPIL, WITHOUT COMPLICATIONS. ON FINAL EXAMINATION (AFTER IOL CENTRATION), COMPLAINTS OF LOW VISION AT MEDIUM DISTANCE AND NEAR. OPTICAL COHERENCE TOMOGRAPHY (OCT) OF THE RETINA WAS WITHOUT PATHOLOGY. AN ELECTROPHYSIOLOGICAL EXAMINATION REVEALED A CONDUCTION DISTURBANCE ALONG THE VISUAL PATHWAY. RIGHT EYE ARTIFAKIA, AND AMBLYOPIA. SUSPECTED PARTIAL ATROPHY OF THE OPTIC NERVE. THE PATIENT WAS FITTED WITH GLASSES FOR NEAR +2.0, INSTILLATION OF TEAR SUBSTITUTES AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS).

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15788162 ↗
• MalfunctionOct 21, 2022Crack; Crack

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATES THAT DOCTOR IMPLANTED A COMPANY LENS ON PATIENTS EYE. UPON INSPECTION, HE NOTICED THAT THERE IS A CRACK ON THE IOL OPTIC. THE IOL IS STILL ON THE PATIENT'S EYE. DOCTOR WILL SCHEDULE THE EXPLANT SURGERY NEXT WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649835 ↗
• InjuryOct 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15595460 ↗
• InjuryJun 27, 2022Break; Device Dislodged or Dislocated; Insufficient Device Problem Information; Break; Device Dislodged or Dislocated; Insufficient Device Problem Information

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE IOL WAS EXPLANTED DUE TO MEDICAL REASONS.

  Patient problems: Blurred Vision; Capsular Bag Tear; Insufficient Information

  MAUDE report 14831434 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DIFFICULTY IN SEEING NEAR AND DISTANCE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 14331337 ↗
• MalfunctionApr 12, 2022Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT, THERE WAS A PARA CENTRAL TRACE ON IOL, MAYBE MADE BY THE INJECTOR. THE LENS REMAINED IMPLANTED IN PATIENT'S EYE. ADDITIONAL INFORMATION WAS RECEIVED BY THE SURGEON THAT, THE PATIENT DID NOT SEEM TO BE BOTHERED BY THE LENS DURING HIS POST-OP VISIT AFTER 7 DAYS FOLLOWING THE INITIAL IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14080862 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR UPCLOSE VISION AND HAD VISUAL DISTURBANCE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13575684 ↗
• InjuryDec 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT FELT THAT THE IMAGE WAS SPREADING WITHOUT ANY SPECIFIC MATTERS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. NO MORE INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 13125402 ↗
• InjuryDec 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE EYE WAS SETTLING WELL. THERE ARE STILL CORNEAL SUTURES IN SITU AND THESE WILL BE REMOVED NEXT WEEK SO NO FINAL VISUAL OUTCOME TO REPORT YET.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment

  MAUDE report 13088357 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED NEAR VISION WAS SIGNIFICANTLY DECREASED, WHICH DIDN'T MEET THE TARGET. THE LENS WAS REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12338947 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT IN THE SURGEON¿S OPINION THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE EVENT WAS CAUSED BY A REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR THE SAME MODEL WITH A 1.5 DIFFERENCE OF DIOPTER POWER. THE PATIENT¿S ISSUES HAVE RESOLVED. THE PROGNOSIS IS EXCELLENT.

  Patient problems: Blurred Vision

  MAUDE report 11752194 ↗
• MalfunctionMar 5, 2021Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available; Device Contamination with Chemical or Other Material; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED UPON IMPLANTING AN INTRAOCULAR LENS (IOL), THERE WAS A GREY DEPOSIT IN THE CENTER OF THE IMPLANTED LENS. THERE WAS NO REPORTED PATIENT HARM. DURING A FOLLOW UP CHECK, THE SURGEON DID NOT SEE THE DEPOSIT IN THE LENS ANY LONGER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423013 ↗